Growth and Safety of a Two-stage Feeding System in Preterm Infants

Nestlé

Status: Completed

Conditions: Preterm Infant

Treatments: Other: Preterm infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT03728764

17.14.INF

Details and patient eligibility

About

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

Full description

This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.

Enrollment: 34 patients

Sex: All

Ages: Under 5 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
2. Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
3. Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
4. Infant is clinically stable.
5. Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.

Exclusion criteria

1. Parents not willing / not able to comply with the requirements of study protocol.
2. Infants experiencing early onset sepsis.
3. Major congenital or chromosomal abnormality known to affect growth.
4. Preterm infants experiencing liver failure.
5. Peri-/intra-ventricular haemorrhage.
6. Infant requiring prolonged (more than 3 doses) of steroid treatment.
7. Infants' participation in another interventional clinical trial.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

single arm

Other group

Treatment:

Other: Preterm infant formula